An interventional study of Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent. and ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent. in Astigmatism, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
This is a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens.
417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.
This study's enrollment of 281 is above the median of 55 across 325 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →Johnson & Johnson Vision Care, Inc. is the lead sponsor of 221 studies on the registry; 1 is open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 103 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
In both eyes, have astigmatic refractive error suitable for correction with the toric contact lens powers available in this study:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens followed by the Control Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.
Device: Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent. · Device: ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent.
Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens followed by the Test Lens bilaterally for approximately 1-week each in a daily disposable modality with a washout period of approximately 1-week between wear periods.
Device: Investigational daily disposable, soft, toric lenses manufactured on 4th Generation Technology (4GT) lines with extended mini-stack hydration using propylene glycol (PG) as the hydration solvent. · Device: ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) soft contact lenses manufactured on 3rd Generation Technology (3GT) legacy lines using isopropyl alcohol (IPA) as the hydration solvent.
Test Lens
Control Lens
Distance Monocular logMAR Visual Acuity
Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Time frame: 1-Week Follow-up
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Absolute rotation was assessed for each subject eye using a slit lamp 15 minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported for each lens.
Time frame: 15-Minutes after Lens Insertion
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees
Rotational Stability was assessed for each subject eye using a slit lamp 15 minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was reported for each lens.
Time frame: 15-minutes after lens insertion
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and were graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.
Time frame: Up to 1-Week Follow-up
Proportion of Eyes With Acceptable Lens Fitting
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.
Time frame: Up to 1-Week Follow-up
CLUE Vision Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 1-Week Follow-up
CLUE Comfort Score
Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 1-Week Follow-up
CLUE Handling Score
Subjective handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 1-Week Follow-up
| Milestone | Test (Senofilcon A)/Control (Senofilcon A) | Control (Senofilcon A)/ Test (Senofilcon A) |
|---|---|---|
| Started | 135 | 139 |
| Completed | 135 | 138 |
| Not completed | 0 | 1 |
| Withdrew: Subject no longer meets eligibility criteria | 0 | 1 |
| Milestone | Test (Senofilcon A)/Control (Senofilcon A) | Control (Senofilcon A)/ Test (Senofilcon A) |
|---|---|---|
| Started | 135 | 138 |
| Completed | 134 | 138 |
| Not completed | 1 | 0 |
| Withdrew: Protocol deviation wrong left lens cylinder power dispensed | 1 | 0 |
Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
| logMAR | Test (Senofilcon A) | Control (Senofilcon A) |
|---|---|---|
| Distance Monocular logMAR Visual Acuity | -0.099 ± 0.0724 | -0.099 ± 0.0719 |
Absolute rotation was assessed for each subject eye using a slit lamp 15 minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported for each lens.
| Proportion of eyes | Test (Senofilcon A) | Control (Senofilcon A) |
|---|---|---|
| Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees | 0.9871 | 0.9852 |
Rotational Stability was assessed for each subject eye using a slit lamp 15 minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was reported for each lens.
| Proportion of eyes | Test (Senofilcon A) | Control (Senofilcon A) |
|---|---|---|
| Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees | 1 | 1 |
Slit Lamp Findings (SLF) were assessed using a biomicroscope and were graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.
| Proportion of Eyes | Test (Senofilcon A) | Control (Senofilcon A) |
|---|---|---|
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | 0 | 0.002 |
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.
| Proportion of Eyes | Test (Senofilcon A) | Control (Senofilcon A) |
|---|---|---|
| Proportion of Eyes With Acceptable Lens Fitting | 1 | 1 |
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
| Units on a scale | Test (Senofilcon A) | Control (Senofilcon A) |
|---|---|---|
| CLUE Vision Score | 67.57 ± 19.844 | 69.76 ± 18.858 |
Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
| Units of a scale | Test (Senofilcon A) | Control (Senofilcon A) |
|---|---|---|
| CLUE Comfort Score | 61.78 ± 23.808 | 65.33 ± 22.450 |
Subjective handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
| Units of a scale | Test (Senofilcon A) | Control (Senofilcon A) |
|---|---|---|
| CLUE Handling Score | 69.08 ± 22.193 | 70.45 ± 20.367 |
Collected over Throughout the duration of the study; The study duration for each subject was approximately 21 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test (Senofilcon A) | 0/273 (0%) | 0/273 (0%) | 0/273 (0%) |
| Control (Senofilcon A) | 0/272 (0%) | 0/272 (0%) | 0/272 (0%) |
All subjects dispensed at least one study lens.
| Age, Continuous(Years) | Overall Reporting Group |
|---|---|
| Mean | 29.6 ± 6.16 |
| Sex: Female, Male(Participants) | Overall Reporting Group |
|---|---|
| Female | 171 |
| Male | 103 |
| Race (NIH/OMB)(Participants) | Overall Reporting Group |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 15 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 17 |
| White | 231 |
| More than one race | 5 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Overall Reporting Group |
|---|---|
| United States | 274 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Data sharing details ↗ · yoda.yale.edu
Ran from Apr 2025 to primary completion in Jul 2025, 2 months.
Results were first posted in Sep 2026, 1 year 2 months after primary completion.
Of 106 industry-sponsored interventional studies with no phase under Astigmatism, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's 2 months is below that.
Counting every sponsor, half of 183 studies reached it within 12 months; a quarter within 4 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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